Buckleys Formo Cresol

BUCKLEYS FORMO CRESOL- cresol liquid
Dentsply LLC, Professional Division Trading as “Sultan Healthcare”

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

DIRECTIONS FOR USE

REF – 10203 – Buckley’s Formocresol – 1oz/30mL
NPN number: Buckley’s Formocresol — 00470155
For dental use only.

1. DESCRIPTION

Buckley’s Formocresol: 19% formaldehyde, 35% cresol, 17.5% gylcerine.

2. INDICATIONS

Indicated as a disinfectant and devitalizing solution used as part of endodontic treatment.

3. CONTRAINDICATIONS

This product should not be used with individuals with known sensitivities to formaldehyde or cresol. This product should not be used with individuals who are pregnant or suspected to be pregnant without a prior physician consultation.

4. PRECAUTIONS

This product can cause severe burns of skin and mucosa. Take precautions protect skin, mucosa and eyes during use.

5. WARNINGS

Do not swallow. Do not allow material to come into contact with intact skin or mucosa. Wear eye protection when handling. Ensure proper tooth isolation, including rubber dam when applying. Keep out of reach of children. For professional dental use only.

6. DOSAGE AND ADMINISTRATION

1. Intracanal disinfection in permanent teeth: Isolate the tooth with a rubber dam. Clean, de-bride and instrument the canals. Rinse and dry the canal spaces. Moisten a small cotton pellet with Buckley’s Formocresol. Blot or wring any excess liquid from the pellet. Place the cotton pellet in the pulp chamber and seal the access hole with a temporary filling material. Recall the patient after a minimum of 48 hours and remove the pellet. Complete the endodontic treatment and restore.
2. Buckley’s Formocresol pulpotomy in primary teeth: Isolate the tooth with a rubber dam. Remove visible caries. Remove the coronal pulp with an excavator or bur leaving the radicular pulp. Achieve hemostasis. Moisten small cotton pellets with fomocresol. Blot or wring any excess liquid from the pellet. Place the pellets directly on the radicular pulp stumps for 5 minutes. Place a base or a core in the tooth and restore.

7. STORAGE

Store between 59°-86°F (15°-30°C). Protect from freezing.

Manufactured for:
Sultan Healthcare
1301 Smile Way • York, PA 17404-0807 • USA
Toll Free: 800-637-8582 • Phone: 201-871-1232
Fax: 201-871-0321 • www.sultanhealthcare.com

Made in the USA
0010601DF, R1-080714

Principal Display Panel — 30 mL bottle

BUCKLEYS FORMO CRESOL cresol liquid

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0699-0203 Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CRESOL (CRESOL) CRESOL 350 mg in 1 g

Inactive Ingredients Ingredient Name Strength FORMALDEHYDE GLYCERIN

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0699-0203-01 33.57 g in 1 BOTTLE, GLASS None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 02/19/1963

Labeler — Dentsply LLC, Professional Division Trading as “Sultan Healthcare” (167087753)

Establishment
Name	Address	ID/FEI	Operations
Dentsply Caulk		083235549	MANUFACTURE (0699-0203)

Revised: 01/2022 Dentsply LLC, Professional Division Trading as “Sultan Healthcare”